Abstract

A surgical instrument for treating female urinary incontinence comprises a shank (10)
having a handle (11) at one end thereof, and two curved needle-like elements (21A, 21B)
which can be connected one at the time with the shank at the other end thereof to form a
curved end portion of the shank and are attached at one end thereof each with one end of a
netting (26) which is intended to be implanted into the body and is covered by a thin
plastic sheath (34).

Description

[0001]

The invention relates to a surgical instrument for
treating female urinary incontinence, of the type described
in PCT/SE95/00964 the content of which is incorporated
herein by reference, comprising a shank having a handle at
one end thereof, and two curved needle-like elements which
are each attached at one end thereof to one end of a tape
to be implanted into the body, and are constructed to be
connected one at the time with the shank to form a curved
portion at the other end thereof each element being
intended to be passed into the body via the anterior
(suburethral) vaginal wall and being dimensioned to extend
from the inside surface of the vaginal wall over the back
of the pubic bone to the outside of the abdominal wall.

[0002]

The object of the invention is to further improve the
surgical instrument disclosed in said document and for this
purpose the instrument of the invention has obtained the
characterizing features of claim 1.

[0003]

The invention will be explained in more detail with
reference to the accompanying drawings which disclose the
surgical instrument according to the invention and wherein.

FIG. 1 is a side view of the surgical instrument
according to the invention,

FIG. 2 is a plan view of the surgical instrument,

FIG. 3 is an exploded side view of one of the needles
and tape and shrinkage hose to be connected with said
needle,

FIG. 4 is a side view of the needle in FIG. 3 with the
tape connected therewith,

FIG. 5 is an enlarged fragmentary axial cross sectional
view of a coupling of the instrument for connecting
an exchangeable needle thereof, and

FIG 6 is a side view of two needles and a tape interconnecting
said needles.

[0004]

In the following description the same reference numerals
have been used as in PCT/SE85/00964 for corresponding
details of the instrument.

[0005]

The surgical instrument comprises a cylindrical tubular
shank 10 having at one end thereof a handle 11. At the
other end of the shank there is a socket 14. A cylindrical
shaft 15 is rotatably mounted in the shank and can be
rotated manually by means of a knob 16 mounted to one end
of the shaft. The other end of the shaft forms a cylindrical
portion 17, FIG 5, of smaller outside diameter than
the shaft, which joins a portion 18 having external
threads, a smooth end portion 19 of further reduced diameter
joining the threaded portion 18, end portion 19
forming a guide pin at said other end of the shaft.
Portions 18 and 19 are received in the portion of socket 14
projecting from the shank. The surgical instrument as
described so far is in agreement with the instrument disclosed
in PCT/SE95/00964 except that the end portion 14' of
socket 14 is flattened from opposite sides (cfr FIGS 1 and
2), so that the cross section of said end portion is non-circular.

[0006]

The surgical instrument also includes an exchangeable
and disposable needle 21 which at one end thereof is
attached to the shank at one end of the needle and extends
over substantially a quarter of a circle to the other, free
end thereof in order to follow substantially the profile of
the pubis between the vagina and the abdominal wall. The
needle has uniform circular cross section and has a smooth,
preferably polished outside surface. At the free end
thereof the needle forms a point 22 by being terminated by
a conical portion.

[0007]

For attachment of needle 21 to shank 10 the needle
forms at said one end thereof a straight portion 30 which
is cylindrical but has milled flat faces 31 over that part
of said portion 30, extending from the adjacent end of the
needle, which shall be received by socket portion 14'. The
needle should be oriented in a predetermined rotational
position in relation to the shank, and more particularly it
should project at right angles to the plane of handle 11.
This rotational position is secured by the non-circular
shape of socket portion 14' and the end portion of the
needle having the flat faces 31, which fits into socket
portion 14'. The end portion of the needle having the flat
faces 31 joins the body of the needle over e conical portion
32, which tapers towards a shoulder 33.

[0008]

An axial blind hole extends from the end surface of
the needle said hole having a threaded portion 23 and
inwardly thereof a narrower, cylindrical portion 24. Guide
pin 19 is dimensioned to be guidingly received by said
latter portion when the threaded portion 18 for attaching
needle 21 to the rest of the surgical instrument is screwed
into threaded portion 23 of the blind hole by rotating
shaft 15 by manual rotation of knob 16, the end surfaces of
the shank and the needle being pressed against each other.
Also this attachment is in agreement with that described in
PCT/SE95/00964.

[0009]

When the method as described in PCT/SE95/00964 is
practised two needles 21A and 21B, FIG. 6 of the embodiment
described shall be connected one at each end of a tape 26.
According to the present invention the tape of the preferred
embodiment comprises a mesh or netting forming openings
of the order of 1 mm. A suitable material for the
tape is PROLENE®, a knitted polypropylene mesh having a
thickness of 0,7 mm manufactured by Ethicon, Inc., Sommerville,
New Jersey, USA. This material is approved by FDA in
USA for implantation into the human body. The netting
(tape) preferably has a width of approximately 10 mm and is
enclosed in a thin polyethylene sheath 34 which in
flattened condition has substantially the same width as the
tape although a difference in width is shown in FIG 2 in
order to make the provision of the sheath more clear. The
length of the netting should be approximately 400 mm. The
netting and the sheath are interconnected by means of two
rows 35 of stiching. The end portion of the sheath is
attached to the conical portion 32 of the needle by means
of a suitable strong glue, and the interconnection of the
needle and sheath is covered by a shrink hose 36 of rubber
which extends from the shoulder 33 over the conical portion
32 and partly over the cylindrical end portion 30 of the
needle. The shrink hose is substantially flush with the
surface of the needle at the shoulder. By this arrangement
the netting is securely attached to the needle.

[0010]

The purpose of sheath 34 is above all to facilitate
the insertion of the netting in the manner described in
PCT/SE95/00964 i e when the netting is pulled at the ends
thereof from the vaginal wall to the abdominal skin and to
avoid that rough edges of the netting irritate or damage
the body tissues.

[0011]

When the tape has been positioned in the correct position
as a sling around the urethra the polyethylene sheath
shall be removed, and in order to facilitate the removal
the sheath should be perforated at the longitudinal center
thereof as indicated by a dot-and-dash line 37 in FIG. 6,
so that the two halves of the sheath can be withdrawn from
the body by pulling at the respective outer ends thereof
the halves being separated at the perforation under the
influence of the pulling force.

[0012]

The purpose of the polyethylene sheath is also to protect
the netting during attachment to the needles and
during handling before and during insertion into the body.

[0013]

The longitudinal center of the tape and sheath should
be indicated by a visible colour mark 38, FIG. 6 so that
the surgeon readily can see when the netting is symmetrically
located with reference to urethra during the
surgery.

Claims (12)

Surgical instrument for treating female urinary
incontinence, comprising a shank (10) having a handle (11)
at one end thereof, and two curved needle-like elements
(21) which are each attached at one end thereof to one end
of a tape (26) to be implanted into the body, and are
constructed to be connected one at the time with the shank
to form a curved portion at the other end end thereof each
element being intended to be passed into the body via the
anterior (suburethral) vaginal wall and being dimensioned
to extend from the inside surface of the vaginal wall over
the back of the pubic bone to the outside of the abdominal
wall, characterized in that the tape comprises
a netting (26) enclosed by a thin plastic sheath (34).

Instrument as in claim 1 characterized in that the netting (26) is made of polypropylene.

Instrument as in claim 2 characterized in that the sheath (34) is made of polyethylene.

Instrument as in any of claims 1 to 3
characterized in that the sheath (34) is perforated
at the longitudinal center thereof.

Instrument as in any of claims 1 to 4
characterized in that the netting (26) and the
sheath are interconnected by stitching ((35).

Instrument as in any of claims 1 to 5
charactarized in that the needle-like element
(21) comprises a non-circular end portion fitting into a
non-circular socket (14') at said other end of the shank
(10).

Instrument as in claim 6
chararacterized in that said end portion of
the needle-like element (21) joins the rest of the element
by a conical portion (32) tapering towards a shoulder (33)
on the needle-like element.

Instrument as in claim 7 characterized in that the netting (26) and the sheath (34) are connected
to the needle-like element (21) by gluing to said
conical portion (32).

Instrument as in claim 8 characterized in that the netting (26) and the sheath (34) at the
site of attachement thereof are covered by a shrink hose
(36) .

Instrument as in claim 9 characterized in that one end of the shrink hose (36) abuts the
shoulder (33) and is substantially flush with the surface
of the needle-like element at said shoulder.

Instrument as in claim 9 or 11,
characterized in that the netting (26) and the
sheath (34) project from the shrink hose (36) at the other
end thereof.

Instrument as in any of claims 1 to 11,
characterized in that a visable marking (38)
is provided on the sheath (34) at the longitudinal center
thereof.